Onsite Services

Process Training Seminars

  • Onsite general or custom tailored training seminars combine classroom theory with hands-on process applications on client equipment.
  • One to three day programs include topics such as:
    • high shear granulation/fluid bed drying
    • fluid bed spray granulation
    • pelletizing and particle coating (top spray, Wurster or tangential spray techniques)
    • scale-up and troubleshooting, including data analysis.
  • Presentations will include participant feedback and a test to demonstrate and document the effectiveness of the program.
  • Each attendee will be given a binder containing the presentations and a certificate of completion.

Preferred Provider Agreements

This alternative is intended for clients who wish to pursue a broad range range of projects, without specific near-term needs. For an annual fee, priority clients will be provided with onsite consultation (with reasonable travel expenses billed as incurred). The number of trips and duration will be identified, as will the participants (staff and client sites). Off-site services will be provided as well, including data review and summaries, conference calls and timely written responses to inquiries to support client reporting and filings. OWI-Consulting will endeavor to reply to all inquiries within 24 hours.

Per Diem Consultation

For clients who have immediate or short term needs, OWI-Consulting will travel to a client site for a per diem fee (plus reasonable travel expenses), subject to schedule availability. For example, a per diem consultation might address acute troubleshooting during product/process development or for sudden and inexplicable batch failures in the course of routine production.

Project Based Consulting

OWI-Consulting will assist in longer duration and/or specific projects. For an identified product, examples include scale-up/tech transfer, process justification batches, and finally, process validation activities. The overall project protocol will be drafted to define milestones, acceptance criteria, payments and opt-out clauses. These may include but are not limited to the following: writing protocols, evaluating equipment (including performance and IQ ranges), executing experiments/batches, writing protocol summary reports, identifying and writing process recipes including operating ranges for critical process parameters, and the training of operators, supervision and other support staff.

 
 
 
 
 
 
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